FDA.reportPublic FDA data

Enbrel 50 MG in 1 mL Prefilled Syringe

RxCUI
802652
RxNorm name
Enbrel 50 MG in 1 mL Prefilled Syringe
Display name
Enbrel 50 MG in 1 mL Prefilled Syringe
Full name
Enbrel 50 MG in 1 mL Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:11

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103795Enbreletanercept351(a)Disc2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ENBRELETANERCEPTImmunex Corporationa002b40c-097d-47a5-957f-7a7b1807af7f2026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 802652

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
a002b40c-097d-47a5-957f-7a7b1807af7fEnbrel 50 MG in 1 mL Prefilled SyringePSN218These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL ® (etanercept) injection, for subcutaneous use ENBREL ® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 199820260511
a002b40c-097d-47a5-957f-7a7b1807af7f1 ML Enbrel 50 MG/ML Prefilled SyringeSY218These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL ® (etanercept) injection, for subcutaneous use ENBREL ® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 199820260511
a002b40c-097d-47a5-957f-7a7b1807af7f1 ML etanercept 50 MG/ML Prefilled Syringe [Enbrel]SBD218These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL ® (etanercept) injection, for subcutaneous use ENBREL ® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 199820260511
2dc2ed4b-f234-4ccc-bd95-0b63ac3ef4211 ML Enbrel 50 MG/ML Prefilled SyringeSY1These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL . ENBREL ® (etanercept) injection , for subcutaneous use ENBREL ® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 199820191003
2dc2ed4b-f234-4ccc-bd95-0b63ac3ef421Enbrel 50 MG in 1 mL Prefilled SyringePSN1These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL . ENBREL ® (etanercept) injection , for subcutaneous use ENBREL ® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 199820191003
2dc2ed4b-f234-4ccc-bd95-0b63ac3ef4211 ML etanercept 50 MG/ML Prefilled Syringe [Enbrel]SBD1These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL . ENBREL ® (etanercept) injection , for subcutaneous use ENBREL ® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 199820191003